FDAFDA · Food and drugs·Recall number Z-0725-2025
KIT,SPINE LH Convenience kit, SKU DYNJ906448A.
Published January 1, 2025 · Recall initiated: November 6, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US Nationwide. Canada.
- Lot
- UDI-DI: 10193489408508(each), 40193489408509(case); Lot Number: 21EBG271 21CBS664 20LBO883 20WBE707
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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